Squamous Cell Carcinoma of the Oral CavityPhase 2/3DIREKHT2NCT06030440
De-Intensification of Postoperative Radiotherapy in Patients With Squamous Cell Carcinoma of the Head and Neck
A Phase 2/3 study testing Eliminating RT to the elective neck in people with Squamous Cell Carcinoma of the Oral Cavity and Squamous Cell Carcinoma of the Larynx, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
This randomized, prospective, multicenter phase II/III trial will study the reduction of radiation volume by eliminating radiotherapy (RT) to the elective neck using strictly defined surgical and radio-oncological standards to reduce radiotherapy-related long-term side effects without affecting locoregional control. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of the Oral Cavity, Squamous Cell Carcinoma of the Larynx, Squamous Cell Carcinoma of the Hypopharynx
- What is being tested?
- Eliminating RT to the elective neck
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 508 participants
- Where
- 1 siteGermany
- Study dates
- 26 Jan 2024to Sep 2033
- Phase
- Phase 2/3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven squamous cell carcinoma of the oral cavity/larynx/oro-or hypopharynx (except glottis cancer (pT1/2pN0))
- Surgery of primary tumor and neck dissection performed according to predefined surgical standard
- Indication for postoperative radio(chemo)therapy
- No lymph node metastases > 6cm
- Lymph node metastases in not more than 3 lymph node level
- No distant metastases (cM0)
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- Age ≥ 18 years, no upper age limit
- Eastern Cooperative Oncology Group (ECOG) ≤ 2
- Patients who understood protocol contents and are able to behave according to protocol
- Signed study-specific consent form prior to therapy
- Start of radiotherapy at least 6 weeks after last tumor-specific surgery (e.g. resection primary tumor, neck dissection, excluded are surgeries according to wound healing complications)
Who cannot join
- macroscopic incomplete resection R2
- Distant metastases (cM1)
- Radiologically or histologically proven early recurrence after surgery (time frame from surgery to start of radio(chemo)therapy)
- Lymph node metastases in > 3 lymph node level
- pregnant or lactating/nursing women
- fertile patients that are not willing to use highly effective methods of contraception (per institutional standards) during treatment
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- Any condition potentially hampering compliance with the study protocol and follow-up schedule
- On-treatment participation on other clinical therapeutic trials
- Prior tumor-specific therapy any other than surgery (like prior radiotherapy in the head and neck region, prior chemo- or immunotherapy (neoadjuvant/induction))
- Patients who have contraindication for MRI and CT with contrast agent (both)
- Prior (> 2 months before beginning of radio(chemo)therapy) neck dissection or surgery in the head and neck area affecting lymph drainage
- History of another primary malignancy except for malignancy treated with curative intent and with no known active disease ≥5 years before diagnosis of head and neck cancer, adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease, adequately treated carcinoma in situ without evidence of disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Universitätsklinikum Erlangen, Strahlenklinik
Erlangen, Bavaria, 91054
Marlen Haderlein, PD, +49913185 ext. 33968, marlen.haderlein@uk-erlangen.de
Rainer Fietkau, Prof, +49913185 ext. 33968, rainer.fietkau@uk-erlangen.de
About this study
This randomized, prospective, multicenter phase II/III trial will study the reduction of radiation volume by eliminating radiotherapy (RT) to the elective neck using strictly defined surgical and radio-oncological standards to reduce radiotherapy-related long-term side effects without affecting locoregional control.
Read the detailed description
This study aims to determine whether it is possible to achieve an individual target volume concept that eliminates elective irradiation of uninvolved lymph drainage areas while maintaining clearly defined surgical standards and using modern imaging and radiation techniques. The aim of this study is to achieve reduced late toxicity without compromising locoregional control.
Patients will be randomized to: either RT to primary tumor region, regions with lymph node metastases and elective nodal irradiation (control arm) or RT to primary tumor region and regions with lymph node metastases without elective nodal irradiation (investigational arm)
A two-stage design was chosen for this purpose.
Phase II:
A randomized phase II study whose primary endpoint is the 1-year percutaneous endoscopic gastrostomy (PEG) tube dependence rate will be performed first.
Phase III:
If the primary endpoint of the phase II study is met and the interim analysis shows no increase in the locoregional recurrence rate in the study/investigational arm, the study will be continued as a phase III study whose primary endpoint is the locoregional control rate.
- Conditions
- Squamous Cell Carcinoma of the Oral Cavity, Squamous Cell Carcinoma of the Larynx, Squamous Cell Carcinoma of the Hypopharynx, Squamous Cell Carcinoma of the Oropharynx
- Being tested
- Eliminating RT to the elective neck, RT standard of care
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eliminating RT to the elective neckRadiation
Reduction of radiation volume by eliminating radiotherapy to the elective neck
RT standard of careRadiation
postoperative radiotherapy of the head and neck region according to current standard including elective nodal irradiation
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | Active comparator | postoperative radiotherapy of the head and neck region according to current standard including elective nodal irradiation Receives: Radiation: RT standard of care |
| Investigational Arm | Experimental | postoperative radiotherapy of the head and neck region without elective nodal irradiation Receives: Radiation: Eliminating RT to the elective neck |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase II: 1-year PEG feeding tube dependence rate
observe change of PEG-dependence due to different target volumes
Measured: PEG-dependent 1 year after radiotherapy
Phase III: Time to local relapse
difference between the date of randomization and the date of observation of local relapse (LR), or the date of last observation if no LR occurred (censored observation)
Measured: From the date of randomization until the date of observation of local relapse or the date of last observation if no LR occurred, whichever came first (assessed up to 26 months)
Secondary outcomes (6)
Disease-free survival
Disease-free survival
Measured: up to 26 months
Distant-metastasis-free survival
Distant-metastasis-free survival
Measured: through study completion, an average of 26 months
Overall survival (OS)
Overall survival (OS)
Measured: up to 26 months
Cause of death (tumor-related, not tumor-related)
Cause of death (tumor-related, not tumor-related)
Measured: through study completion, an average of 26 months
Acute toxicity according to Common Terminology Criteria (CTC) version 5.0
Acute toxicity according to CTC version 5.0
Measured: up to 2 months
Late toxicity according to CTC version 5.0
Late toxicity according to CTC version 5.0
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start26 Jan 2024
- Primary completionDec 2031 (estimated)
- Study completionSep 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma of the Oral CavityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 508 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarina Müller, PD, Study director, Universitätsklinikum Erlangen, HNORainer Fietkau, Prof, Principal investigator, Universitätsklinikum Erlangen, Radiation Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06030440
- Sponsor's protocol ID
- DIREKHT2
- Acronym
- DIREKHT2
- Status last verified
- Jan 2026
- First submitted
- 11 Aug 2023
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No